510(k) Report

Devices descending from K120962

7 later devices reach Pathassist Light Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+2K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+3K212774VenSure LightGuideIntersect Ent.20221—
+3K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+4K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+4K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+4K201398SINUSPRIME Dilation SystemStryker Ent20200—